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Kulzer, Inc.

Last updated September 17, 2026

What Kulzer, Inc. makes

Kulzer, Inc. manufactures dental materials including resin artificial teeth, dental composite resins, veneer resins for prostheses, polyether impression materials, and laboratory CAD/CAM dental milling systems. Their portfolio also includes dentine bonding agents and specialized dental resins for restorative and prosthetic applications.

The company’s products are classified as Class II medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database. Kulzer, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Kulzer, Inc. manufacture?

Kulzer, Inc. specializes in dental materials and systems. Their portfolio includes resin artificial teeth, dental composite resins, veneer resins for dental prostheses, polyether impression materials for dental impressions, and laboratory CAD/CAM dental milling systems. They also produce dentine bonding agents and specialized resins for restorative and prosthetic dental applications, all designed for use in dental procedures.

Where is Kulzer, Inc. based?

Kulzer, Inc. is headquartered in the United States. The company focuses on developing and manufacturing dental materials and systems primarily for use in clinical and laboratory settings.

Which regulatory registries list Kulzer, Inc.’s devices?

Kulzer, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.

How are Kulzer, Inc.’s devices classified under medical device regulations?

Kulzer, Inc.’s devices fall under Class II medical device classification. This classification applies to products that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as dental materials and systems used in restorative or prosthetic procedures.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 4315 S. Lafayette Blvd., SOUTH BEND, IN, 46614
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1821514
DUNS Number: —

Catalogue (6131)

Page 77 of 123

Device	Model / Reference	Registries	Class	Status
Artic digital 8, BL3 / 20 degree-32 UD, CE	66983241	FDA UDI	Class II	Active
Artic digital 8, B3 / 20 degrees-30LD, CE	66080711	FDA UDI	Class II	Active
Artic	66080630	FDA UDI	Class II	Active
Artic 8, C1 / 0 degree - 32 L, CE	66015192	FDA UDI	Class II	Active
Mondial 6, C2 / O510, CE	66017136	FDA UDI	Class II	Active
Artic 6, A1 / L 50, CE	66012924	FDA UDI	Class II	Active
Artic digital 8, A2 / 20 degree-32 UD, CE	66983193	FDA UDI	Class II	Active
Basic 8, B1 / EU, CE	56739582	FDA UDI	Class II	Unknown
Artic 8, A3.5 / 30 degree - 32 U, CE	66037015	FDA UDI	Class II	Active
Mondial 6i, A3 / T4, CE	66970507	FDA UDI	Class II	Active
Basic 6, D3 / U05, CE	56739319	FDA UDI	Class II	Unknown
Basic 6, C3 / L01, CE	56739076	FDA UDI	Class II	Unknown
Artic	66080572	FDA UDI	Class II	Active
Artic 6, A1 / TO 40, CE	66012889	FDA UDI	Class II	Active
Artic 8, C3 / 0 degree - 30 U, CE	66015209	FDA UDI	Class II	Active
Mondial 6, C2 / L398, CE	66017150	FDA UDI	Class II	Active
Mondial 8, A1 / 28L, CE	66802105	FDA UDI	Class II	Active
Artic digital 6, A3 / T20D, CE	66080310	FDA UDI	Class II	Active
Basic 8, C3 / EU, CE	56739588	FDA UDI	Class II	Unknown
Signum Opaque F	66020069	FDA UDI	Class II	Active
VENUS DIAMOND PLT REFILL 2x10x0, 25G A2	66039009	FDA UDI	Class II	Active
Basic 8, D2 / FO, CE	56739606	FDA UDI	Class II	Unknown
Mondial 6, B3 / L369, CE	66017061	FDA UDI	Class II	Active
Artic 8, D2 / 0 degree - 30 U, CE	66015229	FDA UDI	Class II	Active
Signum cre-active	66020059	FDA UDI	Class II	Active
Mondial 6, BL2 / L378, CE	66801044	FDA UDI	Class II	Active
Mondial 6i, B2 / L12, CE	66970604	FDA UDI	Class II	Active
Artic 8, A2 / 30 degree - 32 L, CE	66037004	FDA UDI	Class II	Active
Artic 8, B4 / 0 degree - 32 L, CE	66015182	FDA UDI	Class II	Active
Mondial 6, B3 / T442, CE	66017045	FDA UDI	Class II	Active
Artic 6, B1 / L 30, CE	66012914	FDA UDI	Class II	Active
Premium 6, B4 / T4, CE	66007163	FDA UDI	Class II	Unknown
Artic 8, A4 / 20 degree - 30 U, CE	66014118	FDA UDI	Class II	Active
Artic 6, A3.5 / T 20, CE	66012850	FDA UDI	Class II	Active
Mondial 8, C3 / 31 U, CE	66017403	FDA UDI	Class II	Active
Mondial 6, D3 / T442, CE	66017241	FDA UDI	Class II	Active
VENUS SYR 1 x 4G - OC3	66007602	FDA UDI	Class II	Unknown
Signum Opaque F	66020079	FDA UDI	Class II	Active
Flexitime	66100481	FDA UDI	Class II	Active
HeraCeram Modellierflussigkeit MLS, 25ml	66003541	FDA UDI	Class II	Unknown
Flexitime Xtreme Correct Fl. Ref.12x50ml	66019687	FDA UDI	Class II	Unknown
Basic 8, A2 / CO, CE	56739434	FDA UDI	Class II	Unknown
Artic 6, C3 / TO 05, CE	66015027	FDA UDI	Class II	Active
Delara	66071278	FDA UDI	Class II	Active
Delara	66071359	FDA UDI	Class II	Active
Artic 6, C4 / S 35, CE	66015040	FDA UDI	Class II	Active
Venus Bulk Fill Syr Refill 1 x 1, 8G	66046795	FDA UDI	Class II	Unknown
HeraCeram Opalschneide OS1, 100g	66003461	FDA UDI	Class II	Unknown
Venus Diamond	66081839	FDA UDI	Class II	Active
Basic 8, A3 / CU, CE	56739451	FDA UDI	Class II	Unknown

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FDA Establishments (2)

Establishments registered with the FDA under this company group, matched by name.

Kulzer Gmbh HANAU Hesse · DE FEI 3005665377
Kulzer SRL Sacalaz-Judet Timis · RO FEI 3011203516